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How men rate symptom score changes

 

Clinical bottom line

At least a moderate benefit is seen with a reduction of about 5 points in the AUA symptom score.


Reference

MJ Barry et al. Benign prostatic hyperplasia specific health status measures in clinical research: how much change in the American Urological Association symptom index and the benign prostatic hyperplasia impact index is perceptible to patients? Journal of Urology 1995 154: 1770-1774.

Study

This study looked at symptom scales in BPH, and examined how changes were rated by participants in a clinical trial. The men in the study were at least 45 years old, with BPH, a peal urinary flow of 4 to 15 mL/second, and on no antihypertensive agents other than diuretics or ACE inhibitors. They had to have a score on the AUA system of at least 8 points (out of a possible 35).

Self-administered questionnaires were used at baseline, and after randomisation to one of four treatment arms. Questionnaires included the AUA symptom list and the BPH impact index. They completed these same questionnaires during the study and at 52 weeks. At each visit patients and physicians rated improvement from baseline on a five-point scale (marked, moderate, slight, no improvement, or worse).

Results

Baseline information was available on 1,229 men, with an average age of 65 years and a mean AUA score of 16 points, a mean maximum urinary flow rate of 10.5 mL/second, and a median prostate volume of 58cc.

Bothersomeness and AUA symptom score

Patients with more bother had higher AUA symptom scores (Table 1). Those with none at all had a mean AUA score of 12 points, while those with a lot of bother had a score of 24 points.

Table 1: Bother and AUA score (Question - how bothersome has any trouble with urination been in the last week?)

Bother

Number

AUA

95% CI

Not at all

264

12.4

11.8-13.0

A little

565

14.4

14.0-14.9

Some

343

19.2

18.6-19.7

A lot

57

23.6

22.2-25.1

Improvement and change in AUA score

At 13 weeks patients scored their global assessment of improvement, and the change in AUA symptom score was examined by category of global improvement (Table 2). Those with a marked improvement had a large (9 point) reduction in symptom score. Those with less good improvement had smaller changes, while those with no improvement or were worse had no change or increased symptom scores.

Table 2: Change in AUA score with global assessment at 13 weeks

Improvement

Number

Mean AUA improvement

Mean percentage improvement

Marked

223

8.8

57

Moderate

298

5.1

32

Slight

347

3.0

16

None

253

0.7

2

Worse

24

-2.7

-19

These changes were more marked in men with higher rather than lower baseline scores. For instance, in men with lower baseline scores, a moderate improvement was a reduction of 4 points on the AUA, while for those with higher baseline scores it was an improvement of 8.7 points.

Comment

After about a year on finasteride, the average reduction in symptom score is about 4.5 points on the AUA symptom score. On average it is a moderate benefit: for some men that is a moderate benefit, and for others a slight benefit. With placebo, the average reduction in symptom scores is 2 points, somewhere between no change and a slight benefit.

This is useful information, and it would be terrific if these levels of clinical benefit could be used as outcomes in BPH studies, or used for a meta-analysis based on individual patient data.